BackgroundMedical device adverse event reporting is an essential activity for mitigating device-related risks. Reporting of adverse events can be done by anyone like healthcare workers, patients, and others. However, for an individual to determine the reporting, he or she should recognize the current situation as an adverse event. The objective of this report is to share observed individual differences in the perception of a medical device adverse event, which may affect the judgment and the reporting of adverse events.MethodsWe trained twenty-three participants from twelve Asia-Pacific Economic Cooperation (APEC) member economies about international guidelines for medical device vigilance. We developed and used six virtual cases and six questions. We divided participants into six groups and compared their opinions. We also surveyed the country's opinion to investigate the beginning point of ‘patient use’. The phases of ‘patient use’ are divided into: 1) inspecting, 2) preparing, and 3) applying medical device.ResultsAs for the question on the beginning point of ‘patient use,’ 28.6%, 35.7%, and 35.7% of participants provided answers regarding the first, second, and third phases, respectively. In training for applying international guidelines to virtual cases, only one of the six questions reached a consensus between the two groups in all six virtual cases. For the other five questions, different judgments were given in at least two groups.ConclusionFrom training courses using virtual cases, we found that there was no consensus on ‘patient use’ point of view of medical devices. There was a significant difference in applying definitions of adverse events written in guidelines regarding the medical device associated incidents. Our results point out that international harmonization effort is needed not only to harmonize differences in regulations between countries but also to overcome diversity in perspectives existing at the site of medical device use.

ObjectiveImmediate medical device adverse event (MDAE) reporting indications of Korea include death, life-threatening, hospitalization (initial or prolonged), disability or permanent damage, and congenital malformation or abnormalities. With the advent of new codes from the International Medical Device Regulators Forum, a study was undertaken to explore the applicability of health impact codes as immediate MDAE reporting indications in the Republic of Korea.MethodThis domestic cross-sectional survey study was conducted for members from Medical Device Safety Information Monitoring Center in November 2019. For the annex F (health impact) codes defining health impact of an MDAE, we checked whether each code matched with the current indication and asked experts whether they agreed with each code as an indication of immediate reporting. Consensus was reached when ≥70% of experts agreed.ResultsA total of 28 experts from 19 centers responded to the survey. Of a total of 64 codes, 29 matched with the current indication. However, in an expert survey, 17 of 29 codes were not agreed for immediate reporting and 5 codes were found to be unmatched codes. For these 5 codes, experts agreed that they would need reporting immediately. Finally, only 17 codes achieved consensus for immediate reporting.ConclusionsThere is a discrepancy between the code matched to the current immediate MDAE reporting indication and experts’ consensus. Sufficient discussion and agreement would be needed to apply health impact codes for immediate reporting.

Purpose: The objective of this study is to verify the economic validation of quality management integrated train freight car by analyzing economic evaluation indicators such as benefit and cost, net present value, and inter rate of return. Methods: First, we itemize benefit and cost field by reviewing literatures; Benefit consists of 1)Safety, 2)Operation, and 3)Maintenance; Cost consists of 1)Set-up fee, 2)Wireless internet fee, and 3)Cloud storage using fee. Second, based on these estimated values, we conduct an economic evaluation analysis. Among them, benefit and cost, net present value, and internal rate of return are selected. Results: As a result, all estimated values are highly over criterion of economic validity(B/C≧1, NPV≧0, IRR≧ R); 1)benefit over cost ratio is 28.22, 2)Net present value is 8,121.66million KRW, and 3)Internal rate of return value is 2272%. Conclusion: The findings of this study will help making a decision when train industry adopts IoT technology for improving the effectiveness.

Purpose: The purpose of this study is to lay groundwork for future research on the outcomes of national quality awards for secondary-care healthcare organizations.Methods: For this study, a secondary-care hospital was selected through a convenience sampling method and all of its organizational members participated in complete enumeration survey using 109 survey questions derived from the MBNQA criteria for healthcare through structural equation modeling (SEM)Results: As a result, Leadership was shown to drive Foundation and Direction, which affect System that creates Results with 12 hypotheses supported out of 18 hypotheses established. Conclusion:The findings of this study will provide valuable implications to the top management of secondary-care hospitals for self-examining quality management and promoting sustainable competitiveness